MAUDE Adverse Event Report: LASIK

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Visual Impairment (2138); Depression (2361)

Event Type  No Answer Provided  

Event Description

I had lasik done 6 months ago. The outcome has changed my life forever. I now have terrible night vision, which now includes huge starburst and glare. My eyes really aren't dry, so i guess i dodged that bullet. The worst thing about it is that fixing my night vision problems would now require a hard rigid lenses designed custom made for my eyes, which may not even fix my problems. Before i had perfect vision with contact lenses. What a terrible mistake i have made. I am only (b)(6) and now for the rest of my life i have to right this devastating condition. Why is lasik even legal, why was i not told directly by the doctors that my large pupil would cause poor night vision. I would give every dime to my name to get my old crappy eyes back that were fixed perfectly with contact lenses. I have considered suicide on several occasions. I have never ever been suicidal my entire life. I am now on antidepressants which i know is the only reason i am here today explaining my struggle. I can no longer enjoy my night outs with my friends, i can't go anywhere at night without a horrible headache from trying to see. I pray and pray that they will find a way to cure this condition. Please shut down lasik.

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 4024257
• Report Number: MW5037734
• Device Sequence Number: 1
• Product Code: LZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Age: 22 YR
• Patient Outcome(s): Disability